Guardian Connect System – P160007
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Guardian Connect System
PMA Applicant: Medtronic MiniMed, Inc.
Address: 18000 Devonshire Street
Northridge, CA, 91325
Approval Date: March 8, 2018
Approval Letter: P160007 Approval Letter
What is it? The Guardian Connect System is a continuous glucose monitoring (CGM) system that measures sugar (glucose) levels every 5 minutes and displays the values through the Guardian Connect app installed on a compatible mobile device (i.e., an iPhone or iPad). The System allows users to detect trends and track patterns in glucose concentrations to help keep blood glucose levels in a safe range. Diabetes is a disease in which your blood sugar or blood glucose levels can go too low or too high.
How does it work? The Guardian Connect System is comprised of the following devices: Guardian Connect app, Guardian Sensor (3), and the Guardian Connect transmitter.
The Guardian Sensor (3) is inserted under the skin of the user’s arm or abdomen and monitors glucose levels in the tissue fluid.
The Guardian Connect Transmitter processes and stores glucose levels from the Guardian Sensor (3) and wirelessly sends these levels to the Guardian Connect app.
The Guardian Connect app is designed to display sensor glucose levels, provide trend information, and to alert the user to low (hypoglycemic) and high (hyperglycemic) glucose levels, based on the alert settings programmed by the user. The app has a user interface for sensor calibration, entering data such as meter blood glucose measurements, exercise and meals, and uploading information to the CareLink® Personal website.
The app is intended for use only by persons using a compatible mobile device, and who have experience to adjust audio and notification settings. For the Guardian Connect System to function properly, the mobile device must be on and fully operational with Bluetooth and notifications for the Guardian Connect app enabled.
When is it used? The Guardian Connect System is intended for continuous or periodic monitoring of glucose levels in the tissue fluid under the skin, in persons fourteen years of age and older with Type I or Type II diabetes. The system requires a prescription.
The Guardian Sensor (3) glucose levels are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a finger stick may be required to measure glucose levels. All therapy adjustments should be based on measurements obtained using a home glucose monitor and not on glucose levels provided by the Guardian Sensor (3).
What will it accomplish? People with diabetes can use the glucose information from the continuous glucose monitor (CGM) to help detect trends and track patterns in their glucose levels. The Guardian Connect System can alert users when glucose levels are approaching potentially dangerously high (hyperglycemic) and/or dangerously low (hypoglycemic) levels. When used along with a blood glucose meter to obtain a more accurate reading of actual blood glucose levels, the Guardian Connect system CGM can also help people with diabetes make long-term adjustments to their treatment plan to keep blood glucose levels in a safe range.
When should it not be used?
The Guardian Connect System should not be used in:
• People unwilling or unable to perform a minimum of two meter blood glucose tests per day
• People unwilling or unable to maintain contact with their healthcare professional
• People whose vision or hearing does not allow recognition of alerts generated by the Guardian Connect app.
Patients should not expose their sensor or transmitter to Magnetic Resonance Imaging (MRI) equipment, diathermy services or other devices that generate strong magnetic fields (for example, x-ray, CT scan, or other types of radiation). Exposure to a strong magnetic field has not been evaluated and can cause the device to malfunction, result in serious injury or be unsafe. If the sensor or transmitter are exposed to a strong magnetic field, use should be discontinued.
Taking medications with acetaminophen including but not limited to Tylenol, fever reducers, cold medicine, or paracetamol while wearing the sensor may falsely raise your sensor glucose readings. The level of inaccuracy depends on the amount of acetaminophen or paracetamol active in the body and may be different for each person.
Additional information (including warnings, precautions, and adverse events): Summary of Safety and Effectiveness and labeling available online.
- American Diabetes Association: Checking Your Blood Glucose
- Center for Disease Control and Prevention: Diabetes
- National Institute of Diabetes and Digestive and Kidney Diseases: Managing Diabetes